CoughNCT06951321
Characteristics of Postinfectious Cough
An observational study of Cough, run by Kefang Lai at 1 site in China.
Trial summary
Collect the age, sex and other demographic data of 1600 patients with chronic cough after COVID-19 infection and clinical parameters such as cough characteristics, establish a cohort of patients with chronic cough after COVID-19 infection, observe the type and level of airway inflammation, airway responsiveness, cough… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- How many people
- 1,650 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cough lasts for more than 3 weeks after COVID-19 infection and there is still cough at the time of investigation
Who may be able to join
- Age between 18-70 years old, gender not limited;
- After COVID-19 infection (COVID-19 nucleic acid test or antigen test is positive, or there is a highly suspected symptom of COVID-19 infection), the cough lasts for more than 3 weeks and there is still cough at the time of investigation;
- No obvious abnormalities were found in chest imaging.
Who cannot join
- Combined with other respiratory infectious diseases (pneumonia, tuberculosis, etc.);
- Combined chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, etc.);
- Cough and expectoration were found 2 months before COVID-19 infection;
- Merge other serious organ diseases and malignant tumors;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Clinical and Pathophysiological Characteristics of Postinfectious Cough Post COVID-19 Infection: a Multi-center Nationwide Research
Collect the age, sex and other demographic data of 1600 patients with chronic cough after COVID-19 infection and clinical parameters such as cough characteristics, establish a cohort of patients with chronic cough after COVID-19 infection, observe the type and level of airway inflammation, airway responsiveness, cough sensitivity and changes in microbiology of patients with chronic cough after COVID-19 infection, clarify the epidemiological characteristics, clinical pathophysiological characteristics, long-term prognosis and related factors of patients with chronic cough after COVID-19 infection, explore the clinical pathophysiological characteristics and pathogenesis of cough after COVID-19 infection, and provide a theoretical basis for the treatment of persistent cough after COVID-19 infection.
Read the detailed description
- Formulate clinical data registration questionnaire (including baseline and follow-up) Adopt the form of online questionnaire survey, unify the inclusion criteria, and register the demographic characteristics of patients with cough after COVID-19 infection and the clinical data of acute infection and migration, including the symptoms of COVID-19 infection in the acute phase, the characteristics related to the current cough symptoms (such as cough phase, nature, severity assessment, etc.), past disease history, current drug use, etc. It is expected that there will be no less than 1600 postinfecitous cough questionnaires. Simultaneously record the laboratory test results of the patient, including blood cell classification count, lung ventilation and bronchial provocation test, induced sputum analysis, fractional exhaled nitric oxide , chest X-ray or CT examination, sputum bacterial culture (for cough patients), besides, some patients have completed cough stimulation tests. Secondly, follow-up visits (12 weeks, 52 weeks) were conducted on the included postinfectious cough patients to record the characteristics and severity of cough symptoms in the delayed patients. Some patients were re-examined for lung ventilation and bronchial provocation tests, cough provocation tests, induced sputum analysis, and fractional exhaled nitric oxide, and the results were recorded. Among them, serum samples (200 cases), sputum supernatant (200 cases), and original sputum (200 cases) were collected.
- Analysis of airway microbiome in postinfectious cough post COVID-19 patients The patients with cough after COVID-19 infection and the healthy subjects matched in age and sex were included. The original sputum was obtained for macro gene sequencing. In addition, the sputum supernatant and sputum cells were separated by induced sputum treatment. The sputum supernatant was used for metabolic group and inflammatory factor detection, the sputum cells were used for transcriptome sequencing, the Illumina HiSeq2500 was used for macro genome and transcriptome sequencing, LC-MS/MS was used for non targeted metabolic group detection, and Luminex multi factor kit was used for inflammatory factor detection. Through dimensional reduction analysis of the obtained multiomics data, a multivariable linear mixed model was established, and clinical indicators were used as covariates to carry out association analysis of the multiomics data, in order to identify the key genes of the cross integration of multiomics biological pathway and the species encoding the gene, and to obtain the "flora metabolism host inflammation" pathway that significantly interacts in the cough after COVID-19 infection, thereby revealing the potential mechanism of COVID-19 infection induced cough persistence.
- Conditions
- Cough
- Keywords
- cough
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough duration
The total cough duration after COVID-19 infection reported by the patient
Measured: From enrollment to 1 year after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Mar 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kefang Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951321
- Sponsor's protocol ID
- ES-2023-032-01
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering that patients are unwilling to disclose their personal privacy information. If necessary, please contact us and we will consider providing it.
Publications
He W, Zhang J, Sun D, Yi F, Wu F, Fei J, Wei X, Zhan W, Geng L, Qin X, Xie H, Jiang M, Wei C, Xu P, Feng C, Wang L, Feng J, Zhang Y, Chen L, Qiu Z, Lu H, Zhang J, Chen M, Jiang Y, Li S, Yin H, Zhu J, Shi L, Han W, Geng X, Tan W, Wang L, Yao H, Bian T, Tang H, Zeng X, Liu B, Lai K. Long-Term Prognosis of Adult Patients with Persistent Cough Post COVID-19 and Its Risk Factors: A Nationwide Prospective Study. Lung. 2026 Mar 18;204(1):15. doi: 10.1007/s00408-026-00879-x.
PubMed 41848877
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Pathophysiological Characteristics of Postinfectious Cough Post COVID-19 Infection: a Multi-center Nationwide Research
- ClinicalTrials.gov ID
- NCT06951321
- Acronym / sponsor ID
- ES-2023-032-01
- Conditions
- Cough
- Keywords
- cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- Kefang LaiUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect the age, sex and other demographic data of 1600 patients with chronic cough after COVID-19 infection and clinical parameters such as cough characteristics, establish a cohort of patients with chronic cough after COVID-19 infection, observe the type and level of airway inflammation, airway responsiveness, cough sensitivity and changes in microbiology of patients with chronic cough after COVID-19 infection, clarify the epidemiological characteristics, clinical pathophysiological characteristics, long-term prognosis and related factors of patients with chronic cough after COVID-19 infection, explore the clinical pathophysiological characteristics and pathogenesis of cough after COVID-19 infection, and provide a theoretical basis for the treatment of persistent cough after COVID-19 infection.
Detailed description
- Formulate clinical data registration questionnaire (including baseline and follow-up) Adopt the form of online questionnaire survey, unify the inclusion criteria, and register the demographic characteristics of patients with cough after COVID-19 infection and the clinical data of acute infection and migration, including the symptoms of COVID-19 infection in the acute phase, the characteristics related to the current cough symptoms (such as cough phase, nature, severity assessment, etc.), past disease history, current drug use, etc. It is expected that there will be no less than 1600 postinfecitous cough questionnaires. Simultaneously record the laboratory test results of the patient, including blood cell classification count, lung ventilation and bronchial provocation test, induced sputum analysis, fractional exhaled nitric oxide , chest X-ray or CT examination, sputum bacterial culture (for cough patients), besides, some patients have completed cough stimulation tests. Secondly, follow-up visits (12 weeks, 52 weeks) were conducted on the included postinfectious cough patients to record the characteristics and severity of cough symptoms in the delayed patients. Some patients were re-examined for lung ventilation and bronchial provocation tests, cough provocation tests, induced sputum analysis, and fractional exhaled nitric oxide, and the results were recorded. Among them, serum samples (200 cases), sputum supernatant (200 cases), and original sputum (200 cases) were collected.
- Analysis of airway microbiome in postinfectious cough post COVID-19 patients The patients with cough after COVID-19 infection and the healthy subjects matched in age and sex were included. The original sputum was obtained for macro gene sequencing. In addition, the sputum supernatant and sputum cells were separated by induced sputum treatment. The sputum supernatant was used for metabolic group and inflammatory factor detection, the sputum cells were used for transcriptome sequencing, the Illumina HiSeq2500 was used for macro genome and transcriptome sequencing, LC-MS/MS was used for non targeted metabolic group detection, and Luminex multi factor kit was used for inflammatory factor detection. Through dimensional reduction analysis of the obtained multiomics data, a multivariable linear mixed model was established, and clinical indicators were used as covariates to carry out association analysis of the multiomics data, in order to identify the key genes of the cross integration of multiomics biological pathway and the species encoding the gene, and to obtain the "flora metabolism host inflammation" pathway that significantly interacts in the cough after COVID-19 infection, thereby revealing the potential mechanism of COVID-19 infection induced cough persistence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cough lasts for more than 3 weeks after COVID-19 infection and there is still cough at the time of investigation
Key inclusion criteria (3 listed)
- Age between 18-70 years old, gender not limited;
- After COVID-19 infection (COVID-19 nucleic acid test or antigen test is positive, or there is a highly suspected symptom of COVID-19 infection), the cough lasts for more than 3 weeks and there is still cough at the time of investigation;
- No obvious abnormalities were found in chest imaging.
Key exclusion criteria (5 listed)
- Combined with other respiratory infectious diseases (pneumonia, tuberculosis, etc.);
- Combined chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, etc.);
- Cough and expectoration were found 2 months before COVID-19 infection;
- Merge other serious organ diseases and malignant tumors;
- Pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cough duration
Time frame: From enrollment to 1 year after the enrollment
The total cough duration after COVID-19 infection reported by the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41848877He W, Zhang J, Sun D, Yi F, Wu F, Fei J, Wei X, Zhan W, Geng L, Qin X, Xie H, Jiang M, Wei C, Xu P, Feng C, Wang L, Feng J, Zhang Y, Chen L, Qiu Z, Lu H, Zhang J, Chen M, Jiang Y, Li S, Yin H, Zhu J, Shi L, Han W, Geng X, Tan W, Wang L, Yao H, Bian T, Tang H, Zeng X, Liu B, Lai K. Long-Term Prognosis of Adult Patients with Persistent Cough Post COVID-19 and Its Risk Factors: A Nationwide Prospective Study. Lung. 2026 Mar 18;204(1):15. doi: 10.1007/s00408-026-00879-x.
- Individual participant dataSharing planned: No. Considering that patients are unwilling to disclose their personal privacy information. If necessary, please contact us and we will consider providing it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by Kefang Lai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough duration (time frame: From enrollment to 1 year after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.